• IEC 60601-2-4:2010+AMD1:2018 CSV

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English - French

    Published date:  28-02-2018

    Publisher:  International Electrotechnical Committee

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of
            ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and
            ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking
            and documents
    201.8 Protection against electrical HAZARDS
            from ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS
            of ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and
            excessive radiation HAZARDS
    201.11 Protection against excessive temperatures
            and other HAZARDS
    201.12 Accuracy of controls and instruments
            and protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL
            SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME
            EQUIPMENT and ME SYSTEMS
    201.101 Charging time
    201.102 INTERNAL ELECTRICAL POWER SOURCE
    201.103 Endurance
    201.104 SYNCHRONIZER
    201.105 Recovery of the MONITOR and/or
            ECG input after defibrillation
    201.106 Disturbance to the MONITOR from
            charging or internal discharging
    201.107 Requirements for RHYTHM RECOGNITION
            DETECTOR
    201.108 DEFIBRILLATOR ELECTRODES
    201.109 External pacing
    202 Electromagnetic compatibility - Requirements and tests
    Annexes
    Annex C (informative) - Guide to marking and labeling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Mapping between the elements of
            the second edition of IEC 60601-2-4 and
            IEC 60601-2-4:2010
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC 60601-2-4:2010+A1:2018 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. This consolidated version consists of the third edition (2010) and its amendment 1 (2018). Therefore, no need to order amendment in addition to this publication.

    General Product Information - (Show below) - (Hide below)

    Committee TC 62/SC 62D
    Development Note Also available in CD-ROM format. Stability Date: 2022. (03/2018)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
    AAMI EC12 : 2000 DISPOSABLE ECG ELECTRODES
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
    AAMI DF39 : 1ED 93 AUTOMATIC EXTERNAL DEFIBRILLATORS AND REMOTE-CONTROL DEFIBRILLATORS
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